National access

A key challenge for a life sciences product manufacturer is to address the varying needs of each national market. The access professional has to understand and satisfy the requirements of these authorities and purchasers.

A good working understanding of the regulatory approval process is invaluable to the access practitioner. 

The marketing authorisation process in some regions such as the European Union may benefit from a central regulator, but the national regulator is a central player in deciding on the early access of a medicine. We describe the national regulator's role in each of our country pages.

Although international agreements are in place for elements of the access process, countries differ considerably in how they implement the process of deciding which treatments to commission and how much they want to pay for them. Despite this variability there is a high degree of commonality in the components of the process itself, and for each of the countries in this section we describe how they address each of these elements of the access process.

In addition, to help visualise the commonalities and distinguish differences across the countries we propose a typology of access approaches.